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External Oblique Intercostal Plane Block Versus rectus sheath Plane Block in Supra-umbilical Surgical Incisions; Randomized Controlled Double Blinded Clinical Trial

Protocol summary

Study aim
Evaluate the postoperative analgesic effects of ultrasound-guided external oblique intercostal block versus rectus sheath block block in patients scheduled for suprumbilical incision
Design
Double blind (participant .assessor) controlled interventional study parallel assigned ,90 patient aged more than 18 years old ,both sex , scheduled for supra-umbilical surgical incision in Mansoura university hospital ,ethical approval will be grunted
Settings and conduct
In Mansoura university hospital , both techniques will be performed after induction of anesthesia by a single operator, bilaterally with real-time ultrasonographic guidance (HFL38x/13- 6 MHz Linear Array Transducer; Sonosite M-Turbo™, Bothell, WA, USA) using a 22G (0.70 mm × 50 mm) Stimuplex® A insulated needle (B. Braun, Melsungen, Germany)
Participants/Inclusion and exclusion criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) grade I -II, Scheduled to undergo elective supra-umbilical surgeries under GA . Exclusion Criteria: Allergy to local anesthetics, Infection at the site of injection, Coagulopathy, Chronic pain syndromes, Prolonged opioid medication, Chronic liver disease, chronic renal disease, and cognitive impairment.
Intervention groups
A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation at the sixth intercostal space in the anterior midaxillary line. A 21G 10 cm needle will be inserted using an in plane approach. The tip of the needle will be placed into the fascial plane on the deep aspect of the external oblique muscle. A volume of 20 mL of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 1% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected.
Main outcome variables
pain score at 1, 3,6 , 9, 12,18,21 and 24 hours postoperatively evaluated by visual analogue score.

General information

Reason for update
Acronym
EOIB
IRCT registration information
IRCT registration number: IRCT20220212054002N3
Registration date: 2023-08-14, 1402/05/23
Registration timing: registered_while_recruiting

Last update: 2023-08-14, 1402/05/23
Update count: 0
Registration date
2023-08-14, 1402/05/23
Registrant information
Name
zenat eldadamony
Name of organization / entity
Mansoura university
Country
Egypt
Phone
+20 122 543 9066
Email address
zenatddd@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-22, 1402/04/31
Expected recruitment end date
2023-11-30, 1402/09/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
External Oblique Intercostal Plane Block Versus rectus sheath Plane Block in Supra-umbilical Surgical Incisions; Randomized Controlled Double Blinded Clinical Trial
Public title
External Oblique Intercostal Plane Block in Supra-umbilical Surgical Incisions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
American Society of Anesthesiologists (ASA) physical status grade I -II Scheduled to undergo elective supra-umbilical surgeries under GA (epigastric herniotomy- gastrectomy-open cholecystectomy- nephrectomy).
Exclusion criteria:
Allergy to local anesthetics,, Infection at the site of injection, Coagulopathy, Chronic pain syndromes Prolonged opioid medication, Chronic liver disease , or chronic renal disease, cognitive impairment.
Age
From 18 years old to 70 years old
Gender
Both
Phase
4
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Enrolled patients will randomly allocated to group (EOIB) and group (RSB) with allocated ratio 1:1 .Randomization will done before surgery by computer generated random ,Version28.0 . Opaque sealed sequentially numbered envelopes containing the patients` codes will used and opened just before anesthesia by physician who will not involved in the study . The patients will be allocated to either group “EOIB”, who receive external oblique intercostal plane block , or group “RSB” who receive rectus sheath plane block , with general anesthesia
Blinding (investigator's opinion)
Double blinded
Blinding description
Anesthesiologist who will perform the block will not be blinded to group assignment. However, participant ,anesthesiologist responsible of the patient , and health care providers who collected the data will be blinded to group allocation.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Institutional Research Board
Street address
Algomhorea street
City
Mansoura
Postal code
35511
Approval date
2023-08-06, 1402/05/15
Ethics committee reference number
R.23.06.2232.R1

Health conditions studied

1

Description of health condition studied
Post operative pain control in super umbilical surgical incision
ICD-10 code
K87
ICD-10 code description
umbilical surgical incision

Primary outcomes

1

Description
POST OPERATIVE PAIN SCORE
Timepoint
24 hours post operative
Method of measurement
VISUAL ANALUGE SCALE

2

Description
amount of postoperative morphine consumed
Timepoint
24 hours post operative
Method of measurement
milligram

Secondary outcomes

1

Description
amount of postoperative morphine consumed
Timepoint
24 hours post operative
Method of measurement
milligram

Intervention groups

1

Description
Intervention group: A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation at the sixth intercostal space in the anterior midaxillary line. A 21G 10 cm needle will be inserted using an inplane approach. The tip of the needle will be placed into the fascial plane on the deep aspect of the external oblique muscle. A volume of 20 mL of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine1% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected.
Category
Treatment - Other

2

Description
Intervention group: The rectus sheath block was performed bilaterally with real-time ultrasonographic guidance (HFL38x/13-6 MHz Linear Array Transducer; Sonosite M-Turbo™, Bothell, WA, USA) using a 22G (0.70 mm × 50 mm)Stimuplex® A insulated needle (B. Braun, Melsungen, Germany) via an in-plane approach to the rectussheath. 10 mL of 1% lignocaine, together with adrenaline 1:200,000, and 10 mL of 0.5% bupivacainewere deposited in the potential space between the rectus abdominis muscle and the posterior rectussheath bilaterally . A total of 30 mL of 1% lignocaine (200 mg) and 20 mL of 0.5% bupivacaine (100 mg)were administered.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mansoura university hospital
Full name of responsible person
Zenat Eldadamony Mohamed
Street address
Algomhoria street
City
Mansoura
Postal code
35511
Phone
+20 100 726 8585
Fax
Email
zenatddd@gmail.com
Web page address
http://www.mans.edu.eg

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mansoura university
Full name of responsible person
Zenat Eldadamony Mohamed
Street address
Algomhoria street
City
Mansoura
Postal code
35511
Phone
+20 100 726 8585
Email
zenatddd@gmail.com
Web page address
http://www.mans.edu.eg
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mansoura university hospital
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mansoura university
Full name of responsible person
Zenat Eldadamony
Position
Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Algomhoria street
City
Mansoura
Province
Dakahalia
Postal code
35511
Phone
+20 122 543 9066
Fax
Email
zenatddd@gmail.com
Web page address
http://www.mans.edu.eg

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mansoura university
Full name of responsible person
Zenat Eldadamony Mohamed
Position
Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Algomhoria street
City
Mansoura
Province
Dakahalia
Postal code
35511
Phone
+20 100 726 8585
Fax
Email
zenatddd@gmail.com
Web page address
http://www.mans.edu.eg

Person responsible for updating data

Contact
Name of organization / entity
Mansoura university
Full name of responsible person
Zenat Eldadamony Mohamed
Position
Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Algomhoria street
City
Mansoura
Province
Dakahalia
Postal code
35511
Phone
+20 100 726 8585
Fax
Email
zenatddd@gmail.com
Web page address
http://www.mans.edu.eg

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
all collected identified IPD
When the data will become available and for how long
6 month after publication
To whom data/document is available
only available for people working in academic institutions
Under which criteria data/document could be used
IPD and primary outcome
From where data/document is obtainable
zenatddd@gmail.com
What processes are involved for a request to access data/document
email request
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